Skip to main content
OpenTrials
Completed

NCT Number: NCT00214266

A Pilot Study of Campath-1H Induction Therapy Combined With CellCept® Therapy to Allow for a Calcineurin Inhibitor Free Regimen After Renal Transplantation

The hypothesis of this study is that lymphocyte depletion by Campath-1H and rituximab will obviate the need for long-term calcineurin inhibitors in renal transplantation. Most successful strategies to date have relied on the use of either tacrolimus or cyclosporine. However, the advantage of a calcineurin inhibitor free regimen may include improved renal allograft function, a lower incidence of hypertension, diabetes, and less drug related side effects. This is a non-randomized open-label pilot trial in 30 adult renal transplant patients.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Renal Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • renal transplant recipients

Exclusion criteria

  • Recipients of HLA-identical living-donor renal transplants;
  • multi-organ transplant;
  • known hypersensitivity to Campath-1H, Rituximab, CellCept, or prednisone;

Treatment and study plan

Campath 1H®, Rituximab, mycophenolate mofetil

Drug

Induction therapy with Campath 30mg IV x 2 doses, Rituximab 375mg/m2 x 1, corticosteroids, and mycophenolate 1000mg bid

Primary outcomes

  1. renal allograft function

    Time frame: 2 years

Secondary outcomes

  1. incidence of hypertension

    Time frame: 2 years

  2. incidence of diabetes

    Time frame: 2 years

  3. drug related side effects

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Sep 21, 2005
Registry last updated
May 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.